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Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Lonza AG
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Pharmaceuticals & Sterile/OTC Drugs FEI: 3002930340 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Lonza AG

Registered Address: Switzerland (Switzerland)

For Brand Buyers: Lonza AG carries a BBB (72/100) rating due to documented FDA activity centered on Master Manufacturing & Batch Production Records (MMR/BPR). Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): FDA ORA FOIA Electronic Reading Room · Resolved Name Aliases: Lonza AG
BBB
72/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 43th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
BBB (72/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
76%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
61%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
5 Brands
~29 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3002930340's FDA Record

5 Questions to Ask Lonza AG Before Signing a Manufacturing Contract

Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:

  1. Q1: On 2025-10-28, FDA cited 21 CFR 211.188(b)(1) (Master Manufacturing & Batch Production Records (MMR/BPR)). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2025-10-28, FDA cited 21 CFR 211.194(e) (Finished Product Testing, Stability & Expiration Dating). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2025-10-28, FDA cited 21 CFR 211.198(b)(1) (CAPA, Out-of-Specification (OOS) & Complaint Investigations). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  4. Q4: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
  5. Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3002930340?

Cross-Database Regulatory & Inspection Timeline

Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.

Form FDA 483 Issued · 2025-10-28
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Lonza AG (FEI 3002930340) on 2025-10-28 following an inspection of its drug substance manufacturer operations in Switzerland. The report documents 4 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Finished Product Testing, Stability & Expiration Dating.

  • 21 CFR 211.188(b)(1) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
  • 21 CFR 211.194(e) (Finished Product Testing, Stability & Expiration Dating): Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data. REPEAT OBSERVATION
  • 21 CFR 211.198(b)(1) (CAPA, Out-of-Specification (OOS) & Complaint Investigations): Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
  • 21 CFR 211.56(c) (Incoming Ingredient Identity Testing & COA Qualification): Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.

Manufacturer Right-of-Reply & Free Match Correction

GUARDRAIL PROTECTED

To ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.

Dimension 3 · FDA 6-System Model

6-Subsystem cGMP Radar Breakdown

Sub-scores mapped across FDA's six core inspection subsystems.

Quality System (CAPA & OOS) 67/100
Materials & Incoming Identity 65/100
Production & Batch Records 66/100
Facilities, Sanitation & Pest 76/100
Laboratory & Stability Controls 59/100
Packaging & Allergen Labeling 77/100
Layer 6 · Clean-Record Sourcing Alternatives

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Grade AAA · 99/100 Clean Record
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Score Provenance Receipts

Every point in this facility's FDA Record Index (72/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2025-10-28 -7.9 pts INSP-483-3002930340-20251028 ↗
Form 483 (4 observations, 1 repeat) 2025-10-28 -11.9 pts 483-3002930340-20251028 ↗